Bioinductive patch as an augmentation for rotator cuff repair, a systematic review and meta-analysis.

BACKGROUND: Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction. For those who fail initial conservative treatment, operative intervention can be pursued. A significant and common complication after rotator cuff repair (RCR) is retearing or nonhealing. Numerous augmentations to traditional suture RCR have been studied. Of these, the Smith + Nephew Regeneten bioinductive collagen patch has had promising initial results; however, analytic data for its use are lacking, and there is no meta-analysis comparing the available data to historical RCR outcomes. METHODS: A PRISMA-guided literature search was conducted using Ovid MEDLINE, PubMED, Cochrane, and ClinicalTrials.gov. Thirteen studies met inclusion and exclusion criteria. Only clinical trials on full and partial-thickness tears were included. American Shoulder and Elbow Surgeon score, Constant-Murley Score, the visual analog scale for pain, the minimal clinically important difference (MCID), tendon thickness, and complication rates were primary outcomes of interest. A meta-analysis was performed to determine the overall complication and retear rate from the included studies. RESULTS: American Shoulder and Elbow Surgeon score, Constant-Murley Score, and visual analog scale for pain improved significantly in all studies that reported them, and most patients achieved MCID. Patient-reported outcome measure improvements were similar to historical improvements in standard RCR, and a similar proportion of patients achieved MCID after standard repair. Tendon thickness improved significantly and to a similar degree as standard RCR. Overall retear rate after full thickness RCR augmented with the bioinductive patch was 8.3%. For partial thickness RCR, total retear rate was of 1.1% across all patients. The overall complication rate with the bioinductive patch was 15.5% across all full-thickness RCR studies and 16.2% in partial thickness RCR. We found overall retear rate to be lower after augmentation with the bioinductive patch compared to traditional repair; however, the overall complication rate was similar for full-thickness tears and higher for partial-thickness tears. Lastly, adverse reactions to the bioinductive patch were noted at 0.2%. CONCLUSIONS: The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement in patient-reported outcome measures and significant increases in tendon thickness. Retear rate has been a concern after RCR for decades, and the bioinductive patch may help mitigate this risk. There is lack of case-control studies comparing the bioinductive patch to traditional suture RCR. Such data are needed to better determine the role of the bioinductive patch in the treatment of full and partial-thickness rotator cuff repairs.

The neglected barrier to medication use: a systematic review of difficulties associated with opening medication packaging.

Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality of literature pertaining to these issues has yet to be collated and critiqued. This systematic review examined cross-sectional studies that objectively examined the ability of participants to open different medication packaging. Of the 8,692 studies identified, 12 met the inclusion criteria, all of which were direct observational studies given that prior research has identified a mismatch between self-report and actual ability. Scoring via the Appraisal Tool for Cross Sectional Studies revealed that the methodological quality of included studies was typically low. Study samples mostly consisted of older adults. All studies reported a non-negligible proportion of participants unable to open packaging, with the most difficulty associated with child-resistant containers. Several studies examined associations; however, no factor was consistently found to be significantly associated with the ability to open packaging. Despite these studies spanning >40 years, the packaging types examined remained largely the same. This suggests that, despite decades of research demonstrating that packaging is problematic, there has been a stagnation in medication packaging development. Whether this is attributed to a paucity of high-quality research, and therefore a lack of strong evidence that change is needed, is unclear. Future research should strive for better methodological quality, with generalisable cohorts assessed via observation in their home. If the problems identified in prior research persist, this may provide the impetus for change that is overdue in the medication packaging industry.

The Role of the Fracture Liaison Service in Osteoporosis Care.

Osteoporosis is a disease classified by the alteration of bony microarchitecture predisposing a person to fragility fractures. This costs the US $19 billion per year and is expected to rise as our population ages. Only 20% of patients with fragility fractures receive treatment for osteoporosis. A Fracture Liaison Service is a cost-effective way to follow patients and improve appropriate work up and management from multiple medical disciplines.

What Is the Impact of Comorbidities on Self-rated Hand Function in Patients With Symptomatic Trapeziometacarpal Arthritis?

BACKGROUND: The thumb trapeziometacarpal joint is one of the most common sites of arthritic degeneration prompting specialty care. Surgical treatment algorithms are based on radiographic arthritic progression. However, the pain and disability attributable to trapeziometacarpal arthritis do not correlate with arthritic stage, and depression has independently predicted poorer self-rated hand function both at baseline and after treatment in patients' atraumatic hand conditions. QUESTIONS/PURPOSES: (1) Does thumb trapeziometacarpal osteoarthritis impact both self-perceived general health and hand function? (2) Do depression and other comorbid conditions differentially impact patient-rated hand function based on the presence or absence of symptomatic trapeziometacarpal arthritis? (3) How do disease-specific, patient demographics and comorbid conditions impact self-reported hand function in patients with trapeziometacarpal osteoarthritis? METHODS: This cross-sectional study compared patients with symptomatic trapeziometacarpal osteoarthritis (n = 47) with matched control subjects without a symptomatic hand condition (n = 47). All participants self-reported medical (including depression) and musculoskeletal comorbidities and completed the SF-36 and the Michigan Hand Questionnaire (MHQ). Bivariate statistical analyses contrasted the patients with trapeziometacarpal osteoarthritis to control subjects. Linear regression modeling determined the impact of subject demographic data, comorbidity burden, and examination findings on total MHQ scores in patients with trapeziometacarpal arthritis. RESULTS: Patients with scored trapeziometacarpal osteoarthritis indicated poorer perceived general health on the SF-36 categories of limitations resulting from physical health (52 ± 29 versus 71 ± 31, mean difference 19 [95% confidence interval {CI}, 7-31], p = 0.003) and limitations resulting from emotional problems (50 ± 27 versus 67 ± 50, mean difference 17 [95% CI, 3-33], p = 0.022) compared with control subjects. Self-reported depression was associated with worse hand function (total MHQ score) in patients with trapeziometacarpal arthritis (69 ± 20 versus 49 ± 22: mean difference -20 [95% CI, -5 to-36], p = 0.012) but not in control patients (90 ± 13 versus 84 ± 20: mean difference -5 [95% CI, -8 to 19], p = 0.404). In multivariate modeling, depression (ß -20, [95% CI, -5 to -34], p = 0.009) and upper extremity comorbidities (ß -25, [95% CI, -10 to -40], p = 0.002) were both associated with reduced total MHQ scores in patients with trapeziometacarpal osteoarthritis, and those factors accounted for 34% of the variance in the MHQ score. CONCLUSIONS: When interpreting patient-rated hand disability in patients presenting with symptomatic trapeziometacarpal osteoarthritis, scores should be interpreted after accounting for the presence of depression and upper extremity comorbidities. LEVEL OF EVIDENCE: Level III, prognostic study.

Carpal tunnel syndrome and sleep, a systematic review and meta-analysis.

BACKGROUND: The most common symptom and reason patients seek treatment for carpal tunnel syndrome is lack of sleep. Our purpose was to determine how much sleep-related symptoms of carpal tunnel syndrome improve after carpal tunnel release using validated patient-reported outcome measures (PROMs) and objective sleep data as primary measures of interest. METHODS: A PRISMA-guided literature search was conducted using Ovid MEDLINE, PubMed, Cochrane, and ClinicalTrials.gov. Only interventional clinical trials that examined primary outcome measures of interest were included. Patient-reported outcome measures underwent meta-analysis to determine how much scores improved following carpal tunnel release. RESULTS: The Pittsburgh Sleep Quality Index improved significantly after carpal tunnel release, by 4.43 points and 6.02 points at 1-3 and 6-12 months postoperatively, respectively, and continued to improve up to 2 years. Improvement on the Insomnia Severity Index after carpal tunnel release was also significant, with improvement up to 1 year postoperatively, by 8.54 points and 9.05 points at 1-3 and 6-12 months, respectively. Insomnia Severity Index scores improved significantly after splinting as well. CONCLUSIONS: The present meta-analysis determined to what extent patients can expect their sleep to improve after operative and non-operative intervention, as measured by various patient-reported outcome measures that assess sleep. The Pittsburgh Sleep Quality Index and Insomnia Severity Index correlated very well between studies and across hundreds of patients with carpal tunnel syndrome. Data are lacking to define the minimal clinically important difference and assess whether patients achieve a minimal clinically important difference for sleep questionnaires; more information on this topic is needed. LEVEL OF EVIDENCE: III.

Using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement to assess reporting of observational trials in hand surgery.

PURPOSE: To use the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement checklist to critically evaluate the change in quality of observational trial reporting in the Journal of Hand Surgery American between 2005 and 2011. METHODS: A cross-sectional analysis of observational studies published in the Journal of Hand Surgery American was designed to sample 2 6-month periods of publication (March 2005 to August 2005 and June 2011 to November 2011). Fifty-one items were extracted from the STROBE statement for evaluation. Overall STROBE compliance rates for articles and specific checklist items were determined. Final compliance percentages from each period were compared by Student t-testing. Changes in item compliance over time were quantified. RESULTS: Overall compliance with the STROBE statement was 38% (range, 10%-54%) in 2005 and 58% (range, 39%-85%) for 2011 manuscripts representing a significant improvement. Seventy-five percent or greater of articles (2005/2011) provided the explicit reporting of background (100%/97%), follow-up time (85%/94%), overall interpretation of data (100%/94%), and results of similar studies (95%/89%). Twenty-five percent or less of articles provided the study design in the abstract (10%/20%), a clear description of the study's setting (10%/23%), the handling of missing data (0%/6%), the potential directions of bias (5%/11%), and the use of a power analysis (0%/17%). Eighty-six percent (44/51) of items were more frequently satisfied in 2011 articles than in 2005 publications. Absolute increases in compliance rates of 40% or greater were noted in 10 items (20%) with no worsening in compliance for an individual item over 6%. CONCLUSIONS: The overall quality of the reporting of observational trials in the Journal of Hand Surgery American improved from 2005 to 2011. Current observational trials in hand surgery could still benefit from increased reporting of methodological details including the use of power analyses, the handling of missing data, and consideration of potential bias. LEVEL OF EVIDENCE: Diagnostic III.

Minimal clinically important differences of 3 patient-rated outcomes instruments.

PURPOSE: Patient-rated instruments are increasingly used to measure orthopedic outcomes. However, the clinical relevance of modest score changes on such instruments is often unclear. This study was designed to define the minimal clinically important differences (MCIDs) of the Disabilities of the Arm, Shoulder, and Hand (DASH), QuickDASH (subset of DASH), and Patient-Rated Wrist Evaluation (PRWE) questionnaires for atraumatic conditions of the hand, wrist, and forearm. METHODS: We prospectively analyzed 102 patients undergoing nonoperative treatment for isolated tendinitis, arthritis, or nerve compression syndromes from the forearm to the hand. By phone, patients completed the DASH, QuickDASH, and PRWE at enrollment and at 2 weeks (n = 78 used in the analysis) and 4 weeks (n = 24 used in the analysis) after initiating treatment. Patients reporting clinical improvement each contributed a single data point categorized as no change (n = 41), minimal improvement (n = 30), or marked improvement (n = 31) via a validated anchor-based approach. We calculated the MCID as the mean change score for each outcome measure in the minimal improvement group. RESULTS: The MCID (95% confidence interval) for the DASH was 10 (5-15). The MCID for the QuickDASH was 14 (9-20). The MCID was 14 (8-20) for the PRWE. The MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement. The MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores. CONCLUSIONS: Longitudinal changes on the DASH of 10 points, on the QuickDASH of 14 points, and on the PRWE of 14 points represent minimal clinically important changes. We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients. These MCID values may provide a basis for sample size calculations for future investigation using these common patient-rated outcome measures. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic III.

Use of calcium phosphate cement after removal of a cephalomedullary nail: A case report.

Femoral neck fracture in the absence of trauma is a rare, but known complication after hardware removal. This complication may be due to the boney defect created by the hardware removal itself, or the increase in femoral neck strain that occurs after removal of the hardware. Previous biomechanical studies have suggested that filling the defect with calcium phosphate cement after removal of hardware may prevent the development of a femoral neck fracture. However, there are no reports on the use of calcium phosphate cement after removal of hardware in the clinical setting. The purpose of this case discussion is to present the first reported case, to our knowledge, of the use of calcium phosphate cement augmentation of the boney defect after lag screw removal, and the subsequent failure resulting in atraumatic femoral neck fracture.

Methamphetamine Intoxication and Perioperative Complications Following Orthopaedic Surgical Procedures.

Background Methamphetamine use is increasing in prevalence. There is a theoretical increased risk of complication postoperative due to catecholamine depletion. When presented with an urgent surgical problem, there are little data to help counsel the patient on the risks of undergoing surgery in the setting of a positive methamphetamine test result. Aims and objectives The aim of this study was to examine the perioperative complication rate for patients who underwent emergent orthopaedic procedures in the setting of a positive methamphetamine drug screen. Additional data were collected in an attempt to further stratify risk factors for perioperative complications in this patient population. Design and methods A retrospective case series of 110 patients. Patients were identified by querying the medical record for patients with a positive methamphetamine result within 24 hours of the surgery start time. Data were collected on each patient, including the nature of the surgery, the type of injury sustained, disposition from the operating room, among other data points. The primary outcome was the presence of a perioperative cardiopulmonary complication, as determined by a new diagnosis made in the chart. The secondary outcome was whether the patient needed an increased level of care postoperatively. Results Of the 110 charts reviewed, three patients sustained complications during their hospitalization; an overall complication rate of 2.7%. One patient developed acute respiratory distress syndrome (ARDS), while two others developed surgical site infections. Of the 19 patients who went to the intensive care unit (ICU) postoperatively, none were because the patient required a higher level of care than the preoperative level. Conclusions Patients who underwent emergent surgical intervention in the setting of a positive methamphetamine drug test had a low complication rate. While the dogma is to delay surgery in the setting of methamphetamine use, the true risk of undergoing surgery in this setting is not fully understood. We advocate for continued research in this poorly studied group of patients. Larger studies will need to be done in order to fully understand the risks associated with operating in the setting of a positive methamphetamine drug screen.